PRIMAL OK INTERSPINOUS FUSION SYSTEM

K100354 · Osteomed LP · KWP · Aug 17, 2010 · Orthopedic

Device Facts

• Record ID: K100354
• Device Name: PRIMAL OK INTERSPINOUS FUSION SYSTEM
• Applicant: Osteomed LP
• Product Code: KWP · Orthopedic
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PrimaLOKTM SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOKTM SP Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

Device Story

Bilateral locking plate system for posterior spinal fixation; attaches to spinous processes via spikes. Incorporates polyaxial gripping feature to accommodate variations in spinous process morphometry; allows full bony contact. Used in non-cervical spine (T1-S1) by surgeons to provide supplemental stability during fusion procedures. Requires bone graft material; not for stand-alone use. Benefits patient by providing supplemental fixation in degenerative, traumatic, or oncological conditions.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing (compression, tension, torsion) performed per modified ASTM F1717 protocol on worst-case constructs. Results demonstrated performance equivalent or superior to predicate devices.

Technological Characteristics

Bilateral locking plate system; titanium alloy (Ti-6Al-4V) per ASTM F136. Features polyaxial gripping mechanism for spinous process attachment. Mechanical fixation via spikes. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring supplemental spinal fusion in the non-cervical spine (T1-S1) due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Not for stand-alone use; must be used with bone graft material at one level.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• CD Horizon® Spire Plate (K043053)
• Spinous Process Fusion [aka Aspen] Plate (K071877)

Submission Summary (Full Text)

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AUG 1 7 2010

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| 510(k) Summary | | AUG 1 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Date: | 20 May 2010 | |
| Sponsor: | OsteoMed Spine Inc*<br>3885 Arapaho Road<br>Addison, TX 75001 | |
| | Phone: [phone]<br>Fax: [phone]<br>* wholly owned subsidiary of OsteoMed LP | |
| Contact Person: | Rebecca Ellis | |
| | Vice President, RA/QA & Organizational Excellence | |
| Proposed Trade<br>Name: | PrimaLOKTM SP Interspinous Fusion System | |
| Device Classification | Class II | |
| Classification Name: | Spinal interlaminal fixation orthosis | |
| Regulation: | 888.3050 | |
| Device Product Code: | KWP | |
| Device Description: | The PrimaLOKTM SP Interspinous Fusion System is a bilateral<br>locking plate system which attaches to the spine at the<br>spinous processes. It is available in various interspinous<br>heights and widths to accommodate differing anatomic<br>requirements. | |
| Intended Use: | The PrimaLOKTM SP Interspinous Fusion System is a<br>posterior, non-pedicle supplemental fixation device,<br>intended for use in the non-cervical spine (T1-S1). It is<br>intended for plate fixation/attachment to spinous process for<br>the purpose of achieving supplemental fusion in the<br>following conditions: degenerative disc disease (defined as<br>back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies),<br>spondylolisthesis, trauma (i.e., fracture or dislocation),<br>and/or tumor. The PrimaLOKTM SP Interspinous Fusion<br>System is intended for use at one level, with bone graft<br>material and not intended for stand-alone use. | |
| Materials: | The PrimaLOKTM SP Interspinous Fusion System components<br>are manufactured from titanium alloy (Ti-6Al-4V) as<br>described by ASTM F136. | |
| Predicate Devices: | CD Horizon® Spire Plate (Medtronic, K043053) | |
| | Spinous Process Fusion [aka Aspen] Plate (Lanx, Inc.,<br>K071877) | |

参考文献

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### Technological Characteristics:

The PrimaLOKTMsp Interspinous Fusion System possesses the same technological characteristics as one or more of the predicates. These include:

- basic design: bilateral locking plate, having an . interspinous cavity for bone graft that attaches to the spinous processes via spikes.
- material: titanium allov. .
- . sizing: plate sizes are within the range of those in the predicate systems, and
- . intended use: as described above

The PrimaLOK™sp Interspinous Fusion System possesses a modified technological characteristic in that it incorporates a polyaxial gripping feature. This feature permits full boney contact regardless of variations in spinous process morphometry. As the plate is tightened onto the spinous processes, the grips seat and lock. In this final, locked position, the spikes function exactly as the predicates.

Therefore the fundamental scientific technology of the PrimaLOK™sp Interspinous Fusion System is the same as previously cleared devices.

Static compression, tension and torsion, and dynamic compression, and torsion of the worst case PrimaLOK "sp Interspinous Fusion System construct was performed according to a modified ASTM F1717 protocol. The mechanical results demonstrated that the PrimaLOK™sp Interspinous Fusion System performs as well as or better than the predicate device.

#### Performance Data:

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

OsteoMed L.P. % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141

AUG 1 7 2010

Re: K100354

Trade/Device Name: PrimaLOK™sp Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: August 06, 2010 Received: August 09, 2010

Dear Dr. Warden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may; therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Karen E. Warden, Ph.D.

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbara Buehrle

Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100354

# Indications for Use Statement

510(k) Number:

## Device Name: PrimaLOK™sp Interspinous Fusion System

Indications for Use:

The PrimaLOK™ sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOK(" sp Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

Prescription Use _ X

AND/OR

Over-the-Counter Use_

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K100354